Calcelar 25: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Cinacalcet HCl

Indications/Uses

Secondary hyperparathyroidism patients undergoing maintenance dialysis.

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Dosage/Direction for Use

Adult Initially 25 mg once daily, may be adjusted w/in range: 25-75 mg once daily. If no parathyroid hormone improvement, dose may be increased up to 100 mg once daily given as 25 mg at a time w/ at least 3 wk intervals.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity.

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Special Precautions

Adynamic bone disease; hungry bone syndrome accompanied by hypocalcemia & hypophosphatemia. Hypocalcemia; seizure or history of seizure; GI hemorrhage &/or ulcer or history of GI hemorrhage &/or ulcer. Determine serum Ca once wkly prior to initiation, during dose adjustment & at least once every 2 wk during maintenance period; serum parathyroid hormone twice mthly prior to initiation, during dose adjustment & at least once mthly thereafter. May affect ability to drive & use machines. Chronic renal failure patients accompanied by secondary hyperthyroidism who had not yet started dialysis. Hepatic impairment. Not to be used during pregnancy. Avoid use during lactation. Childn, low birth wt infants, newborns, sucklings & infants. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypocalcemia, prolonged QT interval; nausea, vomiting, gastric discomfort, anorexia, abdominal discomfort.

Drug Interactions

Increased plasma conc w/ azole antifungals, macrolides, amiodarone HCl, grapefruit juice. Increased blood conc of TCAs, butyrophenone, antipsychotics, flecainide, vinblastine. Decreased serum Ca level w/ calcitonin, bisphosphonate bone absorption suppressors, corticosteroids. Affected plasma conc w/ digitoxin, diazepam.

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Storage

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Description

View Calcelar 25 description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Other Agents Affecting Metabolism

ATC Classification

H05BX01 - cinacalcet ; Belongs to the class of other anti-parathyroid agents. Used in the management of calcium homeostasis.

Regulatory Classification

Presentation/Packing

Form

Calcelar 25 FC tab 25 mg

Packing/Price

10 × 10's

Calcelar 25

Manufacturer:

Unison

Distributor:

Medispec